Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— V-INCEPTION  

Official title:

A Randomized, Controlled, Multicenter, Open-label Trial Comparing a Hospital Post-discharge Care Pathway Involving Aggressive LDL-C Management That Includes Inclisiran With Usual Care Versus Usual Care Alone in Patients With a Recent Acute Coronary Syndrome(VICTORION-INCEPTION)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04873934
• Other study ID #: CKJX839A1US01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 24, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug,

Description:

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug,

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening
• Serum LDL-C =70 mg/dL or non-HDL-C =100 mg/dL
• Fasting triglycerides <4.52 mmol/L (<400 mg/dL) at screening
• Calculated glomerular filtration rate >20 mL/min by estimated glomerular filtration rate (eGFR)
• Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant patients are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose

Exclusion Criteria:

• New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction <25%.
• Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
• Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
• Treatment with other investigational products or devices within 30 days or five half?lives of the screening visit, whichever is longer.
• Planned use of other investigational products or devices during the course of the study.
• Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening.
• Recurrent ACS event within 2 weeks prior to randomization.
• Coronary angiography and revascularization procedure (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Inclisiran
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Albany	New York
United States	Novartis Investigative Site	Arlington Heights	Illinois
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Bakersfield	California
United States	Novartis Investigative Site	Bartlesville	Oklahoma
United States	Novartis Investigative Site	Bend	Oregon
United States	Novartis Investigative Site	Bossier City	Louisiana
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Brandon	Florida
United States	Novartis Investigative Site	Bridgewater	New Jersey
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Canton	Ohio
United States	Novartis Investigative Site	Cary	North Carolina
United States	Novartis Investigative Site	Charleston	West Virginia
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Colorado Springs	Colorado
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigative Site	Cooperstown	New York
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Daytona Beach	Florida
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Des Moines	Iowa
United States	Novartis Investigative Site	Elmer	New Jersey
United States	Novartis Investigative Site	Erie	Pennsylvania
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Gainesville	Florida
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Hinsdale	Illinois
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Huntsville	Alabama
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jamaica	New York
United States	Novartis Investigative Site	Jonesboro	Arkansas
United States	Novartis Investigative Site	Kalamazoo	Michigan
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Lakewood	Colorado
United States	Novartis Investigative Site	Lancaster	Pennsylvania
United States	Novartis Investigative Site	Lansing	Michigan
United States	Novartis Investigative Site	Lenoir	North Carolina
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Lufkin	Texas
United States	Novartis Investigative Site	Manhasset	New York
United States	Novartis Investigative Site	McKinney	Texas
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami Lakes	Florida
United States	Novartis Investigative Site	Midland	Michigan
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Mission Viejo	California
United States	Novartis Investigative Site	Mobile	Alabama
United States	Novartis Investigative Site	Mullica Hill	New Jersey
United States	Novartis Investigative Site	Munster	Indiana
United States	Novartis Investigative Site	Murray	Utah
United States	Novartis Investigative Site	Newport News	Virginia
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Overland Park	Kansas
United States	Novartis Investigative Site	Palmetto Bay	Florida
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Pinehurst	North Carolina
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Rapid City	South Dakota
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Roanoke	Virginia
United States	Novartis Investigative Site	Rosedale	New York
United States	Novartis Investigative Site	Saginaw	Michigan
United States	Novartis Investigative Site	Saint Cloud	Minnesota
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Salisbury	Maryland
United States	Novartis Investigative Site	Santa Rosa	California
United States	Novartis Investigative Site	Sayre	Pennsylvania
United States	Novartis Investigative Site	Skokie	Illinois
United States	Novartis Investigative Site	Springfield	Missouri
United States	Novartis Investigative Site	Stamford	Connecticut
United States	Novartis Investigative Site	Sunnyvale	Texas
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Toledo	Ohio
United States	Novartis Investigative Site	Torrance	California
United States	Novartis Investigative Site	Torrance	California
United States	Novartis Investigative Site	Troy	Michigan
United States	Novartis Investigative Site	Tupelo	Mississippi
United States	Novartis Investigative Site	Tyler	Texas
United States	Novartis Investigative Site	Washington	District of Columbia
United States	Novartis Investigative Site	Washington	District of Columbia
United States	Novartis Investigative Site	West Hills	California
United States	Novartis Investigative Site	Winchester	Virginia
United States	Novartis Investigative Site	Winston-Salem	North Carolina
United States	Novartis Investigative Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage (%) change in low-density lipoprotein cholesterol (LDL-C)	Inclisiran compared to usual care in reducing LDL-C [percent change] at Day 330 (Year 1)	Baseline and Day 330
Primary	Percentage (%) achieving change in low-density lipoprotein cholesterol (LDL-C) to <70 mg/dl	Inclisiran compared to usual care in achieving LDL-C reduction <70 mg/dl [percent achieved] at Day 330 (Year 1)	Baseline and Day 330
Secondary	Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C)	Inclisiran compared to usual care in reducing LDL-C [absolute change] at Day 330 (Year 1)	Baseline to Day 330
Secondary	Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit	Inclisiran compared to usual care on average percent change from baseline in LDL-C levels after Day 90 and up to Day 330	Baseline, after Day 90 up to Day 330
Secondary	Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit	Inclisiran compared to usual care on average absolute change from baseline in LDL-C levels after Day 90 and up to Day 330	Baseline, after Day 90 up to Day 330
Secondary	Achieving = 50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) (yes, no)	Inclisiran compared to usual care on achieving = 50% reduction from baseline in LDL-C after Day 90 and up to Day 330	Baseline, after Day 90 up to Day 330
Secondary	Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) targets (LDL-C < 100 mg/dL among the subset of participants with LDL-C = 100 mg/dL at baseline, and LDL-C < 55 mg/dL)	Inclisiran compared to usual care on achieving LDL-C < 100 mg/dL (subset of LDL-C = 100 mg/dL at baseline) and LDL-C <55 mg/dl after Day 90 and up to Day 330	Baseline, after Day 90 up to Day 330
Secondary	Percent change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol	Inclisiran compared to placebo in reducing Apo B, very low density lipoprotein (VLDL), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) [Lp(a)], non-high density lipoprotein cholesterol (non-HDL-C), and total cholesterol over time	Baseline and Day 330
Secondary	Absolute change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol	Inclisiran compared to placebo in reducing Apo B, very low density lipoprotein (VLDL), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) [Lp(a)], non-high density lipoprotein cholesterol (non-HDL-C), and total cholesterol over time	Baseline and Day 330
Secondary	Measurement of the intensity of lipid lowering therapy (dose decrease, increase or no change)	Inclisiran compared to usual care on intensity of lipid lowering therapy over time	Baseline and Day 330
Secondary	Percentage of participants discontinuing statin therapy (i.e., no statin use = 30 days before the end-of-study visit)	Inclisiran compared to usual care on discontinuation of statin therapy from baseline to Day 330	Baseline and Day 330